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Study on Lutetium (177Lu) Zadavotide Guraxetan for Prostate Cancer Patients with Biochemical Recurrence After Initial Curative Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a treatment for prostate cancer, specifically for patients who have experienced a return of cancer signs in their blood tests but not in imaging tests after their initial treatment aimed at curing the disease. The treatment being tested is called [177Lu]Lu-PSMA-I&T, which is a type of radioligand therapy. This therapy involves using a radioactive substance to target and treat cancer cells. The study also involves the use of other substances, such as gozetotide and stannous oxide, which are used in the preparation of the treatment.

The purpose of the study is to evaluate how well the treatment works by measuring the response of a protein called prostate specific antigen (PSA) in the blood, which is an indicator of prostate cancer activity. The study will also assess the safety of the treatment by monitoring any side effects that may occur. Participants will receive the treatment through an injection into a vein, and the study will take place over a period of time to observe the effects of the treatment.

Throughout the study, participants will undergo regular check-ups to monitor their health and the effectiveness of the treatment. The goal is to determine if this new therapy can help manage prostate cancer in patients who have shown signs of the disease returning after their initial treatment. The study aims to provide valuable information that could lead to improved treatment options for prostate cancer in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, an initial visit is scheduled. During this visit, a healthcare professional will explain the study details and answer any questions.
You will be asked to sign an informed consent form, confirming your understanding and willingness to participate in the trial.
Step 2
Screening tests
Screening tests are conducted to ensure eligibility. These tests include blood tests to check your white blood cell count, platelet count, hemoglobin levels, and kidney function.
A PET scan may be performed to confirm the absence of local recurrence of prostate cancer.
Step 3
Treatment administration
The treatment involves the administration of [177Lu]Lu-PSMAI&T radioligand therapy through an intravenous injection. This is a solution prepared specifically for the study.
The dosage and frequency of the treatment will be determined by the healthcare team based on your specific condition and response to the therapy.
Step 4
Monitoring and follow-up
Regular follow-up visits are scheduled to monitor your response to the treatment. These visits may include blood tests to measure prostate-specific antigen (PSA) levels and assess any potential side effects.
The healthcare team will evaluate the effectiveness of the treatment and make any necessary adjustments.
Step 5
End of study
At the end of the study, a final evaluation will be conducted to assess the overall response to the treatment.
You will receive information about the results and any further steps or recommendations for your care.

Who can join the trial?

8 criteria

Patients must be 18 years of age or older.
Patients must have been primarily treated for prostate cancer with either surgery (RP) or radiation therapy (RT) and have a PSA doubling-time of 12 months or less. (PSA doubling-time is the period it takes for the prostate-specific antigen level to double, indicating the speed of cancer growth.)
No hormonal therapy in the last 12 months and/or testosterone levels must have returned to normal.
A [68Ga]Ga-PSMA-11 PET scan must show no local recurrence of cancer, but distant metastases (spread of cancer) are allowed. (A PET scan is an imaging test that helps reveal how tissues and organs are functioning.)
Patients must have an ECOG Performance Status of 0-1. (This is a scale used to assess how a patient's disease is progressing, including their level of functioning and ability to care for themselves.)
Patients must have adequate bone marrow reserve: - White Blood Cells (WBC) count of at least 1.5 x 10⁹/L - Platelets count of at least 100 x 10⁹/L - Hemoglobin level of at least 9 g/dL
Patients must have adequate kidney function with an estimated Glomerular Filtration Rate (eGFR) of at least 50 mL/min/1.73m² and an Albumin level of at least 2.5 g/dL. (eGFR is a test that measures the level of kidney function and determines the stage of kidney disease.)
Patients must be able to sign an Informed Consent Form. (This form explains the details of the study, and signing it means the patient agrees to participate.)

Who cannot join the trial?

3 criteria

Patients who do not have prostate carcinoma cannot participate. Prostate carcinoma is a type of cancer that occurs in the prostate gland.
Only male patients can participate. Female patients are not eligible.
Patients who are considered part of a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to give informed consent or are at higher risk of harm.

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Medical University Of Vienna
Vienna, Austria

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Investigated drugs

[177Lu]Lu-PSMAI&T is a type of treatment called radioligand therapy. It is used for patients with prostate cancer who have shown signs of the disease returning after their initial treatment. This therapy works by using a radioactive substance that targets a specific protein found on prostate cancer cells. Once it attaches to the cancer cells, it delivers radiation directly to them, which can help to reduce the size of the tumors or slow their growth. The goal of this treatment is to lower the levels of a marker in the blood called prostate specific antigen (PSA), which can indicate the presence of prostate cancer. Additionally, the study aims to assess any side effects that might occur from this treatment.

What is already known about the treatment

[177Lu]Lu-PSMAI&T – This medication is administered as a radioligand therapy, specifically designed for patients with prostate cancer. It is currently being studied in clinical trials to assess its effectiveness and safety, particularly focusing on its ability to reduce prostate-specific antigen (PSA) levels and evaluate any potential side effects. The main therapeutic use of this medication is for treating prostate cancer, especially in cases where the cancer has returned after initial treatment. At the molecular level, it works by targeting and binding to a specific protein found on prostate cancer cells, delivering radiation directly to the cancer cells to help destroy them. This medication falls under the pharmacological classification of radiopharmaceuticals, which are drugs that contain radioactive substances used to diagnose or treat diseases.

Investigated diseases

Prostate Carcinoma – Prostate carcinoma, commonly known as prostate cancer, is a disease where cells in the prostate gland grow uncontrollably. The prostate is a small gland in males that produces seminal fluid. As the disease progresses, it may spread to nearby tissues or other parts of the body, such as bones and lymph nodes. Early stages often present no symptoms, but as it advances, symptoms may include difficulty urinating, blood in urine, or pelvic discomfort. The progression can vary, with some forms growing slowly and others more aggressively. Monitoring the prostate-specific antigen (PSA) levels in the blood is a common method to track the progression of the disease.